ChemPacific Presentation, Best of Both Worlds

CHEMPACIFIC CORPORATION

Contract Manufacturing of APIs,

Intermediates and Specialty Chemicals

http://chempacific.com/products/

http://chempacific.com/service/

PRESENTATION OUTLINE

Company Overview

Unique Business Model

Chemistry and Technology

Facilities and Equipment

Zhejiang Chempacific

Competitive Advantage

Contact Information

COMPANY OVERVIEW

Began as a New Jersey Corporation in 1995

Moved to Baltimore, Maryland in 1999

>20 employees in the U.S. operation

100% U.S. owned subsidiary in China

• Zhejiang ChemPacific located near Shanghai

• Staffed with over 100 employees

COMPANY OVERVIEW

ZheJiang ChemPacific Growth History

1998

ChemPacific China

Established in

Hangzhou

2000-2004

Manufacture of

>100 Custom

Products

2005-2006

China Operations

Consolidation

In Zhapu

2005

Started GMP

Training Program

2008

Successful FDA

Inspection

2011

Successful FDA

Inspection

COMPANY OVERVIEW

Executive Team

Chen Zhou, Ph.D. CEO Ph.D. New Mexico State Univ.

Post Dr. University of Maine

Tony Liang, MS, MBA - COO/China & US

Operations, Sales Marketing Worked at Novartis Pharmaceuticals

MBA New York

Rebecca Chiu, MS - VP, Global QA/QC Worked at Pfizer 2.5 years

Worked at Novartis Pharma 32.5 years

COMPANY OVERVIEW

Other Key Personnel

Wuyi Wang, Ph.D. - Senior Director of cGMP

program, global

Xianghui Tan, Ph.D. - US Director of cGMP

Production

Jian Huang, Ph.D. - CTO of China Operations

James Havlin, MBA - VP of Sales and Marketing

Peter Wu, PhD. - Head of QC, US

Jinliang Zhang - General Manager, China

Liping Gao, Ph.D - Head of QA/QC, China

COMPANY OVERVIEW

Core Business:

Research and Production of Fine Chemicals, Industrial

Chemicals, Intermediates and APIs

Resources:

Research-driven U.S. Laboratories • Discover and develop products

• Perform small scale cGMP/ Non-GMP manufacturing up to

50kg

Cost-effective plants in China:

Large scale non-GMP/cGMP manufacturing up to 100

metric ton

COMPANY OVERVIEW

R&D Contract and Custom Synthesis:

Unique Projects for Hard to Find Molecules

High Levels of Communications with Researcher

Tech Transfer to China for large scale production

Custom Manufacturing/Intermediates:

Starting with Customer Process or Just a Structure

Process Development and Optimization performed in the

US

Scale-Up to Commercial Quantities performed in China

UNIQUE BUSINESS MODEL

US Facility

Non-GMP and cGMP Manufacturing

Process Development

Lab Scale (up to 1kg)

Kilo Lab (up to 5 kg)

China Facility

Non-GMP and cGMP Manufacturing

Scale-Up Manufacturing

Pilot Plant (5 kg to 1000kg)

Commercial (1 MT to 100MT)

CHEMISTRY AND TECHNOLOGY

HF and KF Fluorination

Per-fluorinated Aromatics

Suzuki Coupling Organics

Organometallic/Oxygen Sensitive

Chiral Synthesis

Unnatural Amino Acids

Indolines and Indoles

Heterocyclic Synthesis


Synthetic organic chemistry expertise

• Non-patent-infringed process route development

• Experience in handling a variety of chemistries with

chiral and non-chiral compounds

• Chemistry R&D and process validation

• Modern Analytical facilities


B. Per-fluorinated Naphthalene

Commercial Scale

Example: Chemical Capability- Per-fluorinated Aromatics

A. Per-fluorinated Benzene


Br

OH

Br-H2O

p-TSA

Functionization of 2-Br-Indene

Commercial Scale

B. Cyclopentadiene Chemistry

Tetramethyl Cp

Pentamethyl Cp

Functionization

Example: Chemical Capability- 2-bromo-indene

A. 2-Br-Indene Chemistry


1. RLi handling capability (Organometallic Chemistry Expertise)

2. Low temperature reaction and handling capabilities

Example: Chemical Capability- Suzuki Coupling Organics

FACILITIES AND EQUIPMENT

Manufacturing Plant in China

ChemPacific Zhejiang:

11 Acre site (expandable to

18 acres)

Capable of Handling Complex

Projects

Compartmentalized

structure gives us the

capability to expand with

customers’ market demands

ZHEJIANG CHEMPACIFIC

General Manager

Jinliang Zhang

COO

Tony Liang

Vice GM

Jian Huang

Global QA/QC

Rebecca Chiu

QA/QC

Liping Gao

R & D

Project

Managers

ESH & Engineering

Xiaokang Hu

Materials

Jiuwang.liu

Finance

Xiaoyan Xi

Sales

Marketing

Huiling Zhu

Administration

Yan Ding

QA

Jianguo Gao

QC

Xingju Wei

Zhejiang ChemPacific Corp.

Organization Chart

Production

Project

Managers



Chemistry Capabilities:

Synthesis Leads to Manufacturing

Custom Synthesis

Specialty Chemical Synthesis and Scale-up

Chemistry from 100 mg to Kilo+

Manufacturing

Scale-up Chemistry for Metric Ton Scale in

China Resulting in Commercial Manufacturing


Process Research and Development

Novel Synthetic Route Selection

Process Optimization and Scale up

Manufacturing of Specialty Chemicals and APIs

cGMP Synthesis

Kilo-Scale for Clinical Trials

Chemistry Capabilities: Process Research and

Manufacturing


RESEARCH to PROCESS DEVELOPMENT TO PRODUCTION

Facility & Engineering Design


Process Development and Scale up Cost Effective API Manufacturing

Zhapu (China)

API Stability Program

Competitive Advantage

Low Cost Supported by World-Class Quality


Raw Material Sourcing Partners

Locally Produced Equipment and Infrastructure

Plentiful Supply of Low Cost Labor

Experienced R&D Chemists and Process Engineers

Dedicated QC and QA teams

Complies to cGMP/FDA Q7 Guildance

Quality Platform and Systems

ChemPacific Quality Program

Platform Product

Quality Systems Risk-based approach

Judgment based on good science

Total Quality Assurance on entire business cycle


Facilities and Equipment,

FDA Inspected Facility

Corporation structure support


Employees: There are 145 employees in Zhapu, 45% have BS degree and

above.

Hours of operation: 3 shifts in production.

Scheduled facility closures: weeks of Chinese New year, May 1 and Oct. 1.

Office

/Sales

10%

Production

44%

QA/QC

9%

R&D

16%

Support

20%


Facilities and Equipment Zhapu,

China Manufacturing Plant

ZHEJIANG ChemPacific, Zhapu (Jan. 2006 in operation)

Located in a Modern Industrial Park

Reaction vessels Up to 5000L

-78°C Reactor (300 L, 1000L and 2000L)

Up to 1000 PSI H2 reactor (300L and 1000L)

High Vacuum/Thin Film Distillation

Particle Forming Spray Dryer Capability

Large-Scale Column Chromatography

Up to MT scale


Generic API-Case#1–Pentostatin

NH

NN

N

OH

OOH

OH

DMF No. 18235

Name: Nipent /Pentostatin

•Market: Anti-tumor Pharmaceutical

•Prior API Process: Fermentation

ChemPacific Process: Total Synthesis of 12 steps

Zhapu: step 1 to step 6 (non-GMP)

Baltimore: step 7 to step 12 (GMP)

US Research-China Production: China: Supply of Advanced Intermediate;

Baltimore: API Manufacture/DMF Submission

Summary:

•ChemPacific Developed the First Chemical Process for API

•ChemPacific Owns the Pentostatin Process Patent

•US-China Synergy Made the Cost Manageable for this

Complex Project


http://www.fda.gov/default.htm

China Production-Case#2

Name: 3,4,5-TricarboxylicAcid-

1-Aminobenzene

Market: Specialty Electronic

Material

US Research-China Production:

Baltimore: Process Development

China: 3-step Custom Manufacture

15,000 kg/Y

CO2HHO2C

NH2

CO2H


China Production-Case#3

Name: p-(4-Formylcyclohexyl) Benzonitrile

Market: Specialty Electronic Material



China: 5-step Reaction Sequence for Single

Customer

R

O

OH

CN

200 kg


China Production-Case#4 Name: 2,3-Difluorophenylacetic Acid

Market: Specialty Electronic Material



China: 3-step Reaction Sequence for a

Single Customer

F

F OH

O

F

F F

1000 kg


Generic API –Case#5– Melphalan HCl

DMF No. 20544

Market: Anti-Cancer, Anti-Neoplastic,

Pharmaceutical API

ChemPacific Process: Total Synthesis of 8 steps

4 steps to starting material – made in Zhapu (non-GMP)

from SM to the step 7 – made in Zhapu (GMP)

last step – was in US (GMP) – has been transferred to

China


http://www.fda.gov/default.htm

COMPETITIVE ADVANTAGE

Domestic Presence Convenience for U.S.

customers

Same time zone

No language barrier

Secure business practices

Troubleshooting handled locally

Small company Personal attention

Flexibility

Quick delivery time

Low overhead- pass lower costs to our clients

http://www.crystalgraphics.com/powerpictures/Image.Search.Details.asp?product=J3121025

COMPETITIVE ADVANTAGE

Experience

Expertise in a wide range of chemistries

Experienced in manufacturing of hard to find molecules

Experienced technical team who recognize the

challenges of transitioning from bench to pre-scale

operations.

Reliable and Financially Stable

A track record of completed projects and satisfied

customers








Some call it the best of both worlds;

we call it, The Best of One World.

CHEMPACIFIC CORPORATION

For more information please contact Chris McRandal, [email protected], (412) 973-9716

mailto:[email protected]

Documents

ChemPacific Presentation, Best of Both Worlds